Garcia‐Burguillo 1996.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 60 adults (macrolide n = 30, placebo n = 30) Age in years (mean ± SD): macrolide: 28.3 ± 5.9, placebo: 27.4 ± 6 Setting: secondary care |
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Interventions |
Indication: preterm rupture of the amniotic membranes Type of macrolide: erythromycin ethyl succinate Route: per oral Dose per day: 2000 mg Duration of treatment: 8 days (mean duration of treatment in erythromycin group) Total treatment dose: 16,000 mg |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: no Adverse events ascertainment: unclear Adverse events: not reported Antimicrobial resistance: not reported Death: reported for babies of treated mothers |
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Funding sources | None reported. | |
Notes | Concomitant medication: yes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear blinding as placebo not described |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only reported on death in babies, which is an objective outcome not influenced by blinding or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | High risk | Adverse events not stated as an outcome, unclear ascertainment, adverse events not reported (only death in babies). |
Other bias | Low risk | None were identified. |